Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-versus-Host Disease

This study has been completed.
Sponsor:
Information provided by:
Therakos
ClinicalTrials.gov Identifier:
NCT00054600
First received: February 5, 2003
Last updated: April 7, 2010
Last verified: April 2010
  Purpose

The purpose of this study is to determine whether Extracorporeal Photopheresis with UVADEX (ECP) prior to bone marrow or peripheral blood stem cell transplantation is effective in the prevention of Graft-versus-Host Disease (GvHD).


Condition Intervention Phase
Graft-Versus-Host Disease
Drug: Methoxsalen
Procedure: Extracorporeal Photopheresis
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Study of Extracorporeal Photopheresis With UVADEX in the Setting of a Standard Myeloablative Conditioning Regimen for the Prevention of Graft-versus-Host Disease in Patients Undergoing an Allogeneic Bone Marrow Transplant or Peripheral Blood Stem Cell Transplant

Resource links provided by NLM:


Further study details as provided by Therakos:

Estimated Enrollment: 60
Study Start Date: June 2002
Estimated Study Completion Date: June 2004
Detailed Description:

Approximately 30% of HLA-identical related bone marrow graft recipients and up to 90% of patients receiving bone marrow from unrelated donors develop significant acute GvHD despite the use of prophylactic therapies such as cyclosporine and methotrexate. About half of these patients respond to initial treatment with steroids and require no further treatment. The remainder of these patients are either unresponsive to initial therapy or become steroid-resistant over time. The prognosis in these cases is poor and mortality for patients with steroid-resistant GvHD may be as high as 50%.

ECP is a technique in which peripheral white blood cells are exposed to a photoactivatable compound (UVADEX) administered extracorporeally and ultraviolet A light. After cells are reinfused into the patient, their function is altered, thereby activating mechanisms that allow for further regulation of specific lymphocyte populations. ECP has shown activity in several inflammatory and autoimmune diseases, including scleroderma, rheumatoid arthritis, transplantation rejection, acute and chronic GvHD.

In a previous single-center, open label, single-arm study of 56 patients receiving ECP treatment on two consecutive days and reduced-intensity bone-marrow conditioning prior to bone marrow transplantation from matched or partially matched human donors, the incidence of grade II-IV acute GvHD was less than 10%. This is in contrast to an expected incidence of approximately 40%.

The purpose of this study is to determine the role of ECP, administered pre-transplant, in preventing GvHD when used in conjunction with a standard myeloablative conditioning regimen.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of a malignancy of the blood (e.g. leukemia) for which allogeneic bone marrow or peripheral blood stem cell transplantation is a treatment option.
  • Patients who are candidates for a standard allogenic bone marrow transplant or PBSC transplant.
  • Patients must have adequate renal, hepatic, pulmonary and cardiac function to enable the patient to tolerate shifts in the volumes of body fluids associated with extracorporeal photopheresis, as determined by the physician's clinical judgement.
  • Patients must weigh at least 40 kg (88 lbs)

Exclusion Criteria:

  • Patients who have received a prior bone marrow transplant or peripheral blood stem cell transplant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054600

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Tufts New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Missouri
Kansas City Cancer Center
Kansas City, Missouri, United States, 64111
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Texas
Texas Transplant
San Antonio, Texas, United States, 78229
Australia
Royal Brisbane Hospital
Brisbane, Australia, 4006
Peter MacCallum Cancer Institute
East Melbourne, Australia, 8006
Alfred Hospital
Melbourne, Australia
Royal Melbourne Hospital
Parkville, Australia, 3050
St. Vincent's Hospital
Sydney, Australia, 2010
Brazil
Hospital Azevedo Carvalho
Jau, Brazil
National Cancer Institute
Rio de Janeiro, Brazil
Hemocentro
Sao Paulo, Brazil
Germany
Ludwig-Maximiliano Universitaet Muenchen
Munchen, Germany, D-81377
Italy
Careggi Hospital
Florence, Italy, 1-50134
San Martino Hospital
Genova, Italy, 16132
Portugal
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, Portugal, 1099-023
Slovakia
National Cancer Institute
Bratislava, Slovakia
Turkey
Ankara University Medical School
Ankara, Turkey, 6100
United Kingdom
Hammersmith Hospital
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Therakos
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00054600     History of Changes
Other Study ID Numbers: GvHD Prevention
Study First Received: February 5, 2003
Last Updated: April 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Therakos:
Extracorporeal Photopheresis
Graft-versus-Host Disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2014